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Probiotics vs. metformin: a new hope for prediabetes?

NCT ID NCT04341571

Disease control Sponsor: University of Guadalajara Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether probiotics can control blood sugar as well as metformin in people with prediabetes. Thirty adults aged 31-60 with prediabetes will take either probiotics or metformin for 13 weeks. The goal is to see if probiotics offer a new treatment option to prevent type 2 diabetes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

31 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients both sexes * Age between 31 and 60 years * Diagnosis of prediabetes according ADA criteria (fasting blood glucose levels between 100-125 mg/dL, postprandial blood glucose levels after an oral glucose tolerance test with 75 g of oral glucose between 140-199 mg/dL and glycated hemoglobin between 5.7-6.4 %) * Body Mass Index from 25 to 34.9 kg/m2 * Stable weight at least the previous last 3 months (weight variation less than 10%) * Acceptance and signing of informed consent Exclusion Criteria: * History of kidney, liver or heart disease * Women with confirmed or suspected pregnancy * Women under lactation and/or puerperium * Physical impossibility for taking pills * Hypersensibility to ingredients of intervention * Consumption of medications or supplements with effects on glucose levels * Systolic blood pressure ≥ 140 mmHg * Diastolic blood pressure ≥ 90 mmHg * HbA1c ≥6.5% * Triglycerides ≥ 400 mg/dL * Total cholesterol ≥ 240 mg/dL

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Conditions

The condition(s) this trial relates to.

glucose intolerance hyperglycemia Insulin Resistance prediabetes syndrome type 2 diabetes mellitus prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperglycemia Impaired glucose tolerance Prediabetes Resistance, insulin

Contacts and locations

Locations

  • INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud

    Guadalajara, Jalisco, 44340, Mexico

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